Tuesday, July 12, 2011

New trial for Pagaclone participants?

A reader informed me that
I’ve been advised that Endo is going to launch a new Pagoclone study involving people who have already participated in the trial.  Interested participants (again, it’s only for those people who have already participated in a Pagoclone trial) should contact Dr. Angelo Sambunaris ...
If the rumour turns out to be true, several questions will arise: Does Endo want to test whether a subgroup benefits from Pagoclone or whether it's just a fata morgana? Who is Dr Sambunaris? What ever happened with Jerry Maguire as chief investigator? Is that the reason he doesn't mention Pagoclone any more? What ever happened with the trial data? Will it be published or not? 

19 comments:

Jim Dunlap said...

Here is the contact information for Dr. Sambunaris (but again it is just for people who have already been participating in a Pagoclone trial).

Angelo Sambunaris, MD, CPI
Medical Director
Atlanta Institute of Medicine & Research
O: 770-817-9200
F: 770-817-9201

Anonymous said...

Could this subgroup be that of first generation stutterers?

I think first generation stutterers could be somehow "different" from those who inherit their stutter

Frank

Tom Weidig said...

I don't understand exactly what you mean by "first generation".

Those that do not have a genetic pre-disposition?

Why would they be more likely to be the subgroup?

Anonymous said...

By first generation stutterers I mean those who don't have relatives who stutter.
I'm one of them.

Anyway that's just a guess...

By the way in my opinion the way Endo is carrying out tesing is just awflul.
Given the (at least partial) effectiveness of voluntary stuttering techniqe is it really so smart for Endo to evaluate the degree of stuttering of patiens the way they do ???

I mean during the interviews , doctors use to evaluate the degree of stuttering of people on testing, they clearly know the patients are stutterers,so this may cause them stutter less than normal, I hope you can see the point.

Frank

Anonymous said...

The testing for pagaclone was terrible. During the double blind phase I was video recorded reading and speaking and my stuttering was severe. During the next phase they placed me on pagalone, my stuttering improved, but they stopped the reading test and video recordings I told them my stuttering was improving and that my wife had noted a change but they always expressed doubts. My stuttering fell off a cliff once I ran out of pagoclone. Its difficult to understand the resistance to marketing a proven safe drug that can provide relief for some stutterers. But a drug like Zypreza is approved for symptoms of psychotic conditions and will cause permament damage if taken long term.

Anonymous said...

There are quite a few drugs in the atypical anti psychotic drug group that are showing some good results in SOME people who stutter.

Anonymous said...

@previous post

Yes,Asenapine is said to be among them.
Dr. Gerald Maguire is testing it
on himself with good results,and he is also going to carry out further
analysis on its real effectivness in the treatment of stuttering.

This article may be of interest:

http://stutter-mind-body.blogspot.com/2010/11/drug-dosages-and-additional-drug.html

These are the latest news I found on Asenapine:

http://ajp.psychiatryonline.org/cgi/content/full/168/6/651-b

If you have more info please share.

Frank

Gerald Maguire, MD said...

Thank you, Frank. We have published our initial case series of asenapine as you state. Our university IRB is currently reviewing our planned asenapine double-blind, placebo-controlled protocol and we are hopeful to begin the study soon. As for pagoclone, Endo is analyzing their next steps and we are hopeful to have an official announcement from them soon. We will be submitting the research article of the recent pagoclone study to a leading journal within the month. When I am able, as I'm bound by confidentiality through the contracted research and through the journal, I will be happy to update everyone on Tom's blog.

Anonymous said...

Dr. Maguire let me cacth this chance to express you my gratituide for your great efforts in trying to treat a changing\destroying life condition such as stuttering.
Your studies are really bringing hope to me as well as to millions of stutterers worldwide.
I will surely stay tuned for more updates.

Frank

Ora said...

Here's a link to Dr. Maguire's recent case reports on asenapine: http://ajp.psychiatryonline.org/cgi/content/full/168/6/651-b

Gerald Maguire, MD said...

Thank you Frank and Ora!

Jerry

olawoyin olaniyi said...

i think i am okey with your write ups and article, yes they are really nice but can you pls include more picture to make us understand you the more?

Anonymous said...

Dr. Maguire

Just a question. Why dont u ask millions of dollars frm the government to find a cure. Im sure with money they will be a cure.

I read that stutters are costing the economy 1 billion dollars but these same stutters if treated can boost the economy by 2 billion dollars or more cuz as a stutterer we all know what we are capable of.

What are your thoughts?

Im frm india so worldwide, we may give a 100 billion dollar boost to the world economy. :)

Anonymous said...

Mostly directed at Jerry, but a good question for the group also. For myself, I did not respond well to several medications in the atypical anti psychotic class for my stuttering. A recent blog entry seems to suggest that psycho-stimulants such as Ritalin or Adderal may prove useful in stuttering. Is anyone having good results with this class of medications?

Ora said...

To the most recent Anonymous:

Can you point us to this blog entry on Ritalin and Adderall?

I thought that the research suggests the opposite: that stimulants increase stuttering. See, for example, http://www.stutteringhelp.org/Default.aspx?tabid=452 and http://www.casafuturatech.com/Book/faq.html

Gerald Maguire, MD said...

To the comments above, we have applied for governmental grants to support our pharmaceutical research but have not been successful. We will continue to try. It appears that the government wants the private sector (i.e. pharmaceutical industry) to cover the costs of medication development.
Psychostimulants, through dopamine agonism, may help a sub-set of individuals who stutter. Usually, these medications tend to worsen stuttering symptoms. If an individual has failed dopamine antagonist therapy, a trial of a GABA compound may be in order as well such as gabapentin or clonazepam.
For Olawoyin, I will include figures and tables in our research article once it is published.

Anonymous said...

Why is this Blog Dead?

Why?

Life has no Meaning....Tom, please come back (and Blog)

Pretty Please!

Anonymous said...

It is possible government funded trails for this medication to treat stuttering has been ended because of fears from the speech therapist that their industry would be decimated with success of this medication. I'm a 52 year old female who has spent a lifetime of using traditional therapies with no change. At present, I am in need of immediate results that will have a positive impact on my life today. Dr. Macguire, please, please advise how I can be evaluate in order to receive this medication.

jNMRdd

junglife said...

In regards to the question of adderall's effect on stuttering, I can offer myself as a purely anecdotal account (so one should not generalize based on my experience).
I'm a 27yo male and have been a stutterer for approximately 22 years. Like many PWS, the severity of my stutter has varied in both severity(mild to severe) and type(blocking or bouncing) over the years. About 5 years ago I was prescribed Adderall for ADD. Over the few 4-6 months, I noticed an improvement in my overall fluency (if I had to guess, I would say it was a 30-40% improvement). The duration/severity of my "blocks" were clearly improved. However, after the initial six months or so, I noticed a return to my usual degree of fluency. The "reversion" seemed analogous to other short lived improvements that I've experienced in the past; such as the use of new "cue words/sounds" or other coping mechanisms that lose their effect after a while.

Has anyone else experienced anything similar?